Benzoyl peroxide

Concomitant application of benzoyl peroxide with tretinoin, isotretinoin, and tazarotene should be avoided since it may reduce their efficacy and increase irritation. If combination treatment is required, the products should be applied at different times of the day (e.g. one in the morning and the other in the evening).

There are limited data on the use of topical benzoyl peroxide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. No effects during pregnancy are anticipated since systemic exposure to benzoyl peroxide is very limited.

However, brevoxyl should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.

Percutaneous absorption of benzoyl peroxide is very limited; however, it is not known whether benzoyl peroxide is excreted in human milk after topical application.

Brevoxyl should be used during lactation only if the expected benefit justifies the potential risk to the infant.

If used during lactation, brevoxyl should not be applied to the breast area to avoid accidental ingestion by the infant.

Fertility

There are no data on the effect of topical benzoyl peroxide on fertility.

Not relevant.

Adverse reactions are classified by System Organ Class. Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented below.

Frequencies were defined as follows:

Very common ≥1/10
Common ≥1/100 to <1/10
Uncommon ≥1/1000 to <1/100
Rare ≥1/10000 to <1/1000
Very rare <1/10000
Not known (cannot be estimated from the available data)

Immune System Disorders

Not known: Allergic reactions, including application site hypersensitivity and anaphylaxis

Skin and subcutaneous tissue disorders

Very Common: Peeling, application site erythema

Common: Dryness, pruritus and contact sensitisation reactions

Uncommon: Burning sensation

Not known: Application site rash

General Disorders and Administration Site Conditions

Not known: Application site discoloration and application site reactions such as irritation and pain